Biopsy device

ABSTRACT

A biopsy device is disclosed. The biopsy device includes a chamber having a body having a distal end and a proximal end, wherein the proximal end includes an inlet. The biopsy device further includes a vacuum generator for generating negative and positive pressure and at least one first recessed area and at least one second recessed area. The first recessed area extends along an inner wall of the body, proximate the proximal end of the body of the chamber. The first recessed area is configured to release pressure within the chamber. The second recessed area extends along the inner wall of the body, proximate the distal end of the body of the chamber. The second recessed area is configured to release pressure within the chamber.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to a biopsy device. Morespecifically, the present disclosure relates to a biopsy device and amethod for extracting a tissue sample therein.

BACKGROUND

In medical procedures, various biopsy devices are used for taking tissuesamples. Typically, a biopsy device includes a hand piece with a hollowbiopsy cannula/needle, a sampling chamber, a sample separatingmechanism, and a pressure generator. A portion of the hollow biopsycannula/needle protrudes from the hand piece and is introduced into thetissue being investigated. A sample of the tissue is sucked into thesampling chamber by vacuum, separated by the sample separatingmechanism, and then removed. The pressure generator, such as a pressurechamber with a single piston, generates the vacuum.

Unfortunately, large amounts of pressure can build-up within thepressure chamber of the biopsy device. The pressure build-up candecrease the efficiency and reliability of tissue extraction from thesampling chamber. Accordingly, there is the need for a biopsy devicethat prevents pressure build-up and provides reliable tissue extraction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a first embodiment of a biopsy device;

FIG. 1A is a side view of a magnified portion of a biopsy device; and

FIG. 2 is a side view of a second embodiment of a biopsy device.

DETAILED DESCRIPTION OF THE DRAWINGS

A biopsy device is disclosed. The biopsy device includes a chamberhaving a body having a distal end and a proximal end, wherein theproximal end includes an inlet. The biopsy device further includes avacuum generator for generating negative and positive pressure and atleast one first recessed area and at least one second recessed area. Thefirst recessed area extends along an inner wall of the body, proximatethe proximal end of the body of the chamber. The first recessed area isconfigured to release pressure within the chamber. The second recessedarea extends along the inner wall of the body, proximate the distal endof the body of the chamber. The second recessed area is configured torelease pressure within the chamber. The biopsy device further includesa cannula coupled to the chamber for taking a tissue sample from apatient.

In another embodiment, a biopsy device is provided. The biopsy deviceincludes a chamber having a body having a distal end, a proximal end,and an inner wall. The proximal end includes an inlet. The biopsy devicefurther includes at least one first recessed area and at least onesecond recessed area. The first recessed area extends along the innerwall of the body, proximate the proximal end of the body of the chamberand is configured to release pressure within the chamber. The secondrecessed area extends along the inner wall of the body, proximate thedistal end of the body of the chamber and is configured to releasepressure within the chamber. The biopsy device further includes a pistonconfigured to engage the inner wall of the chamber and a cannula coupledto the chamber for taking a tissue sample from a patient.

In a further embodiment, a biopsy device is provided. The biopsy deviceincludes a cannula having a body having a distal end, a proximal end. Anorifice is located on a circumferential surface of the proximal end ofthe cannula and is configured to receive a tissue sample into a lumen ofsaid cannula. A pressure chamber is coupled to the distal end of thecannula. The pressure chamber has a body having a proximal end and adistal end. At least one first recessed area extends along an inner wallof the body, proximate the proximal end of the body of the pressurechamber. The first recessed area is configured to release pressurewithin the cannula. At least one second recessed area extends along theinner wall of the body, proximate the distal end of the body of thepressure chamber. The second recessed area is configured to releasepressure within the cannula. Further included is a pressure generatorfor generating a pressure in the pressure chamber and altering apressure in the lumen of the cannula. The biopsy device further includesa cutting sheath slidably and coaxially disposed over the cannula. Thesheath is adapted to seal the recessed area of the orifice.

In yet another embodiment, a method of extracting a tissue sample from abiopsy device is disclosed. The method includes inserting a needle intoa patient's body, wherein the needle is fluidly connected to a chamber.The chamber has a body having a distal end, a proximal end, at least onefirst recessed area, and at least one second recessed area. The firstrecessed area extends along an inner wall of the body, proximate theproximal end of the body of the chamber and is configured to releasepressure within the chamber. The second recessed area extends along theinner wall of the body, proximate the distal end of the body of thechamber and is configured to release pressure within the chamber. Themethod further includes generating a negative pressure environment inthe chamber relative to an atmospheric pressure surrounding the chamberand removing the tissue sample from the patient's body through a suctionresulting from the negative pressure environment. The tissue sample isreceived into a proximal inlet of the cannula. The method includesremoving the cannula from the patient's body, generating a positivepressure environment in the chamber relative to an atmospheric pressuresurrounding the chamber, releasing the positive pressure environmentthrough the first recessed area on the cylindrical body, and removingthe tissue sample from the cannula.

Description of a First Embodiment of a Biopsy Device

Referring initially to FIG. 1, a first embodiment of a biopsy device isdisclosed and is generally designated 100. The biopsy device includes achamber 102 having a body 104 with a proximal end 106 and a distal end108. The proximal end 106 of the chamber 102 can include an inlet 110.In an embodiment, the inlet 110 is configured to provide a fluidconnection between a cannula (not shown) and the chamber 102. Thecannula may include any configuration for severing a tissue sample froma patient. For instance, the cannula may include a knife or a cuttingsheath to sever the tissue sample. In an example, the inlet 110 caninclude a needle hilt 112.

The chamber 102 includes an inner wall 114. Located near the proximalend 106 of the chamber 102 is at least one first recessed area 116. Asseen in FIG. 1A, the wall portion 118 of the recessed area 116 has athickness “t” that is less than the thickness “T” of the inner wall 114.“At least one” first recessed area 116 as used herein includes one ormore recessed area that extends along the inner wall 114 of the proximalend 106 of the chamber 102. The at least one first recessed area 116 isconfigured to release pressure within the chamber 102. The firstrecessed area 116 is illustrated as having a longitudinal shape.“Longitudinal shape” as used herein refers to an opening having anaspect ratio (length to width) greater than about 1.5:1, such as 2:1 andgreater, and is oriented such that the long axis of the opening isgenerally parallel with the longitudinal axis of the chamber.Alternatively, the first opening 116 can have any cross-section that canbe engaged to release pressure within the chamber 102 such as square,rectangular, diagonal, latitudinal, circular, any polygonal shape, or acombination thereof. “Latitudinal” and “diagonal” shapes are elongate asdescribed above with respect to longitudinal shapes, but are positioned(i) generally perpendicular and (ii) generally non-perpendicular and nonparallel to the longitudinal axis of the chamber. Further included alongthe inner wall 114 of the chamber 102 is at least one second recessedarea 120 configured to release pressure within the chamber 102. “Atleast one” second recessed area 120 as used herein includes one or morerecessed area that extends along the inner wall 114 of the distal end108 of the chamber 102. The second recessed area 120 is illustrated ashaving a longitudinal shape. Alternatively, the second recessed area120can have any cross-section that can be engaged to release pressurewithin the chamber 102 such as square, rectangular, diagonal,latitudinal, circular, any polygonal shape, or a combination thereof

The chamber 102 includes a pressure generating device. In an embodimentand as shown in FIG. 1, the pressure generating device may be a piston122 disposed within the chamber 102. The piston 122 is dimensioned toengage the inner wall 114 of the chamber 102. Typically, the piston 122may be of any configuration to engage the inner wall 114 of the chamber102 in a substantially airtight fit. In an example, the piston 122 maybe cylindrical in shape and have an outside diameter. Further, the innerwall 114 of the chamber 102 may be cylindrical in shape wherein theoutside diameter of the piston 122 is more than the diameter of theinner wall 114 to form a substantially airtight fit. “Substantiallyairtight fit” as used herein refers to a frictional fit of the innerwall 114 and the piston 122 to prevent any air from escaping the chamber102 through the distal end 108 of the chamber 102. In an embodiment, thepiston 122 and chamber 102 may be of any suitable configuration toprovide a substantially airtight fit.

As seen in FIG. 1, the piston 122 can include a body 124 having aproximal end 126 and a distal end 128. The proximal end 126 can includea piston seal 130. The piston seal 130 may be configured to provide thesubstantially airtight fit between the inner wall 114 and the piston122. The distal end 128 of the piston 122 can include a stem 132. Thestem 132 is configured to move the piston 122 within the chamber 102.The stem 132 may be incorporated into, or integrally formed with thedistal end 128 of the piston 122. In an exemplary embodiment, as thepiston 122 is depressed, the piston 122 moves toward the proximal end106 of the chamber 102. The stem 132 as illustrated is a bar having athreaded cross-section. Alternatively, the stem 132 can have anycross-section that can be engaged for movement such as square,rectangular, any polygonal shape, or a combination thereof

In a particular embodiment, the stem 132 is depressed and the piston 122advances into the chamber 102 of the biopsy device 100. In particular,depressing the piston 122 toward the proximal end 106 of the chamber 102but distal to the first recessed area 116 generates a positive pressurewithin the chamber 102, relative to an atmospheric pressure. Furtherdepressing the piston 122 to engage the first recessed area 116 releasesthe positive pressure within the chamber 102. In an embodiment, thepositive pressure is normalized to atmospheric pressure. In a furtherembodiment, advancing the piston 122 toward to distal end 108 of thechamber 102 but proximal to the second recessed area 120 generates anegative pressure within the chamber 102, relative to an atmosphericpressure. Further advancing the piston 122 to engage the second recessedarea 120 releases the negative pressure within the chamber 102. In anembodiment, the negative pressure is normalized to atmospheric pressure.

In a further embodiment, generating a negative pressure within thechamber 102 provides pressure capable of removing a tissue sample from abiopsy cavity. The negative pressure provides a suction of the tissuesample from the biopsy cavity. The second recessed area 120 releases thenegative pressure to prevent an excess build-up of pressure. Generatinga positive pressure within the chamber 102 provides pressure capable ofremoving the tissue sample from the biopsy device 100. The firstrecessed area 116 releases the positive pressure to prevent an excessbuild-up of pressure, resulting in a safe sample ejection.

In an embodiment, the chamber 102 may include a fluid receptacle 134.The fluid receptacle 134 may be located at the proximal end 106 of thechamber 102. The fluid receptacle 134 is configured to absorb any excessfluid that is received within the chamber 102 during tissue sampleremoval. The fluid receptacle 134 traps the fluid so the fluids arecontained within the fluid receptacle 134. In an embodiment, the fluidreceptacle 134 may be of any suitable configuration to absorb any bloodor tissue as well as allow air to pass through the fluid receptacle 134.In an embodiment, the fluid receptacle 134 may be an absorbent materialcapable of absorbing fluid. An exemplary absorbent material is fabricsuch as cotton, cellulose, and polyvinyl alcohol (PVA).

Description of a Second Embodiment of a Biopsy Device

Referring initially to FIG. 2, a second embodiment of a biopsy device isdisclosed and is generally designated 200. The biopsy device includes acannula 202. The cannula 202 has a body 204 having a proximal end 206that forms a cutting or piercing leading edge, a distal end 208, and alumen 210 therethrough. The proximal end 206 of the cannula 202 caninclude an orifice 212. The orifice 212 is configured to receive atissue sample. The distal end 208 of the cannula 202 can include apressure chamber 214 having a body 216 with a proximal end 218 and adistal end 220. The pressure chamber 214 includes an inner wall 222.Located near the proximal end 218 of the pressure chamber 214 is atleast one first recessed area 224. The wall portion 226 of the recessedarea 224 has a thickness that is less than the thickness of the innerwall 222. “At least one” first recessed area 224 as used herein includesone or more recessed area that extends along the inner wall 222 of theproximal end 218 of the pressure chamber 214. The at least one firstrecessed area 224 is configured to release pressure within the chamber214 and the lumen 210 of the cannula 202. The first recessed area 224 isillustrated as having a longitudinal shape. Alternatively, the firstrecessed area 224 can have any cross-section that can be engaged torelease pressure within the pressure chamber 214 such as square,rectangular, diagonal, latitudinal, circular, any polygonal shape, or acombination thereof. Further included along the inner wall 222 of thepressure chamber 214 is at least one second recessed area 228 configuredto release pressure within the pressure chamber 214 and within the lumen210 of the cannula 202. “At least one” second recessed area 228 as usedherein includes one or more recessed area that extends along the innerwall 222 the distal end 220 of the pressure chamber 214. The secondrecessed area 228 is illustrated as having a longitudinal shape.Alternatively, the second recessed area 228 can have any cross-sectionthat can be engaged to release pressure within the pressure chamber 214such as square, rectangular, diagonal, latitudinal, circular, anypolygonal shape, or a combination thereof

The pressure chamber 214 includes a pressure generator 230 forgenerating a pressure in the pressure chamber 214 and altering apressure in the lumen 210 of the cannula 202. In an embodiment and asshown in FIG. 2, the pressure generating device 230 may be a piston 232disposed within the chamber 214. The piston 232 is dimensioned to engagethe inner wall 222 of the pressure chamber 214. Typically, the piston232 may be of any configuration to engage the inner wall 222 of thepressure chamber 214 in a substantially airtight fit. In an example, thepiston 232 may be cylindrical in shape and have an outside diameter.Further, the inner wall 222 of the pressure chamber 214 may becylindrical in shape wherein the outside diameter of the piston 232 ismore than the diameter of the inner wall 222 to form a substantiallyairtight fit. “Substantially airtight fit” as used herein refers to africtional fit of the inner wall 222 and the piston 232 to prevent anyair from leaving the pressure chamber 214 through the distal end 220 ofthe pressure chamber 214. In an embodiment, the piston 232 and pressurechamber 214 may be of any suitable configuration to provide asubstantially airtight fit.

As seen in FIG. 2, the piston 232 can include a body 234 having aproximal end 236 and a distal end 238. The proximal end 236 of thepiston 232 can include a piston seal 240. The piston seal 240 may beconfigured to provide the substantially airtight fit between the innerwall 222 and the piston 232. The distal end 238 of the piston 232 caninclude a stem 242. The stem 242 is configured to move the piston 232within the pressure chamber 214. The stem 242 may be incorporated into,or integrally formed with the distal end 238 of the piston 232. In anexemplary embodiment, as the piston 232 is depressed, the piston 232moves toward the proximal end 218 of the pressure chamber 214. The stem242 can have any cross-section that can be engaged for movement such asthreaded, rectangular, any polygonal shape, or a combination thereof

In a particular embodiment, the stem 242 is depressed and the piston 232advances into the pressure chamber 214. In particular, depressing thepiston 232 toward the proximal end 218 of the pressure chamber 214 butdistal to the first recessed area 224 generates a positive pressurewithin the pressure chamber 214 and the lumen 210 of the cannula 202,relative to an atmospheric pressure. Further depressing the piston 232to engage the first recessed area 224 releases the positive pressurewithin the pressure chamber 214 and the lumen 210 of the cannula 202. Inan embodiment, the positive pressure is normalized to atmosphericpressure. In a further embodiment, advancing the piston 232 toward todistal end 220 of the pressure chamber 214 but proximal to the secondrecessed area 228 generates a negative pressure within the pressurechamber 214 and the lumen 210 of the cannula 202, relative to anatmospheric pressure. Further advancing the piston 232 to engage thesecond recessed area 228 releases the negative pressure within thepressure chamber 214 and the lumen 210 of the cannula 202. In anembodiment, the negative pressure is normalized to atmospheric pressure.

In a further embodiment, generating a negative pressure within thepressure chamber 214 provides pressure capable of removing a tissuesample from a biopsy cavity. Hence, the negative pressure provides asuction of the tissue sample from the biopsy cavity. The second recessedarea 228 releases the negative pressure to prevent an excess build-up ofpressure. Generating a positive pressure within the pressure chamber 214provides pressure capable of removing the tissue sample from the biopsydevice 200. The first recessed area 224 releases the positive pressureto prevent an excess build-up of pressure, resulting in a safe sampleejection.

As seen in FIG. 2, the proximal end 206 of the cannula 202 can includean orifice 212. The orifice 212 is located on a circumferential surfaceof the cannula 202. The orifice 212 on the circumferential surface ofthe cannula 202 forms the opening for access of a tissue sample in atissue chamber 244 into the lumen 210 at the proximal end 206 of thecannula 202. In an embodiment, the orifice 212 may further include acutting sheath 246 slidably disposed on the cannula 202. The cuttingsheath 246 may be retracted toward the distal end 208 of the cannula 202to expose the orifice 212 prior to removing a tissue sample from abiopsy cavity. When the proximal end 206 of the biopsy device 200 isplaced in a biopsy cavity in a position to remove a tissue sample, thecutting sheath 246 may be advanced toward the proximal end 206 of thecannula 202 to reliably cut through a tissue sample and maintain thetissue sample within the tissue chamber 244 until sample ejection isdesired.

In an embodiment, the cannula 202 may include a fluid receptacle 248. Ina particular embodiment, the fluid receptacle 248 is located between thetissue chamber 244 and the pressure chamber 214. The fluid receptacle248 may be of any suitable configuration to absorb any excess fluid thatis received within the tissue chamber 244 during tissue sample removal.The fluid receptacle 248 traps the fluid so the fluids are containedwithin the fluid receptacle 248. In an embodiment, the fluid receptacle248 is configured to absorb any blood or tissue as well as allow air topass through the fluid receptacle 248. In an embodiment, the fluidreceptacle 248 may be an absorbent material capable of absorbing fluid.An exemplary absorbent material is fabric such as cotton, cellulose, andpolyvinyl alcohol (PVA).

Description of a Method of Extracting a Sample from a Biopsy Device

An exemplary, non-limiting embodiment of a method of controlling apressure in a biopsy device is provide. In a first step, a biopsy deviceis provided. Subsequently, a cannula is inserted into a patient's body.At the distal end of the cannula is a pressure chamber having a body.The body of the chamber has a distal end and a proximal end. At leastone first recessed area extends along an inner wall of the body,proximate the proximal end of the body of the chamber. The firstrecessed area is configured to release pressure within the chamber. Atleast one second recessed area extends along the inner wall of the body,proximate the distal end of the body of the chamber. The second recessedarea is configured to release pressure within the chamber.

In a next step, a negative pressure environment, relative to anatmospheric pressure, is generated within the chamber. In an embodiment,the negative pressure is generated by advancing a piston toward thedistal end of the chamber. The piston is configured to engage the innerwall of the chamber. In another step, a tissue sample is removed fromthe patient's body into a proximal inlet of the chamber. The tissuesample is removed as a result of the negative pressure environmentgenerated within the chamber. Any fluid flow generated from the tissuesample removal may be absorbed by a fluid receptacle located at theproximal end of the chamber. Typically, the fluid receptacle may be anyabsorbent material capable of absorbing fluid. In a next step, thenegative pressure environment may be released by engaging the secondrecessed area of the chamber. In an embodiment, the negative pressuremay be released to atmospheric pressure. Subsequently, the biopsy deviceis removed from the patient's body.

In another step, a positive pressure environment, relative to anatmospheric pressure, is generated by advancing the piston toward theproximal end of the chamber. The positive pressure is released byengaging the first recessed area of the chamber. In an embodiment, thepositive pressure is normalized to an atmospheric pressure when thefirst recessed area is engaged. Once the positive pressure is released,the tissue sample may be removed from the biopsy device. Subsequently,the method can end.

Conclusion

With the configuration of the structure described above, the biopsydevice provides a device that allows for the safe removal of a tissuesample during a biopsy procedure. Further, the biopsy device is a systemthat does not necessitate the use of additional valves or automatedmeans attached to the biopsy device to release any pressure build-upwithin the device that results in inadequate sample removal from apatient. As such, taking biopsy tissue samples using the biopsy devicedescribed herein is safe and user friendly.

The above-disclosed subject matter is to be considered illustrative, andnot restrictive, and the appended claims are intended to cover all suchmodifications, enhancements, and other embodiments that fall within thetrue spirit and scope of the present invention. Thus, to the maximumextent allowed by law, the scope of the present invention is to bedetermined by the broadest permissible interpretation of the followingclaims and their equivalents, and shall not be restricted or limited bythe foregoing detailed description.

What is claimed is: 1-19. (canceled)
 20. A biopsy device comprising: achamber having a body having a proximal end, a distal end, and an innerwall, wherein the proximal end includes an inlet; a cannula coupled tothe inlet, the cannula configured to take a tissue sample from apatient; a piston configured to engage the inner wall of the chamber; afirst recessed area extending along the inner wall of the body, distalto the proximal end of the body of the chamber, wherein the firstrecessed area is configured to release positive pressure within thechamber, wherein the first recessed area is configured to belongitudinal, diagonal, latitudinal, or circular: and a second recessedarea extending along the inner wall of the body, the second recessedarea being separated distally from the first recessed area, the secondrecessed area being proximal to the distal end of the body of thechamber, wherein the second recessed area is configured to releasenegative pressure within the chamber, wherein the second recessed areais configured to be longitudinal, diagonal, latitudinal, or circular.21-58. (canceled)
 59. The device of claim 20, configured such that asthe piston is moved toward the proximal end of the chamber but distal tothe first recessed area, a positive pressure is generated relative to anatmospheric pressure, and as the piston is moved toward the distal endof the chamber but proximal to the second recessed area, a negativepressure is generated relative to an atmospheric pressure.
 60. Thedevice of claim 20, wherein the positive pressure in the chamber isnormalized to an atmospheric pressure when the positive pressure isreleased.
 61. The device of claim 20, wherein the negative pressure inthe chamber is normalized to an atmospheric pressure when the negativepressure is released.
 62. A biopsy device comprising: a chamber having abody having a proximal end, a distal end, and an inner wall, wherein theproximal end includes an inlet; a cannula coupled to the inlet of thechamber; a first recessed area extending along the inner wall of thebody, distal to the proximal end of the body of the chamber; a secondrecessed area extending along the inner wall of the body, proximal tothe distal end of the body of the chamber; a piston configured to engagethe inner wall of the chamber; and the chamber and piston configuredsuch that as the piston engages the first recessed area, a positivepressure is released through the first recessed area, and as the pistonengages the second recessed area, a negative pressure is releasedthrough the second recessed area.
 63. The device of claim 62, whereinthe positive pressure in the chamber is normalized to an atmosphericpressure when the positive pressure is released.
 64. The device of claim62, wherein the negative pressure in the chamber is normalized to anatmospheric pressure when the negative pressure is released.
 65. Thedevice of claim 62, wherein the first recessed area is configured to belongitudinal, diagonal, latitudinal, or circular.
 66. The device ofclaim 65, wherein the second recessed area is configured to belongitudinal, diagonal, latitudinal, or circular.
 67. The device ofclaim 62, wherein as the piston is advanced toward the proximal end ofthe chamber but distal to the first recessed area, the positive pressureis generated relative to an atmospheric pressure.
 68. The device ofclaim 62, wherein as the piston is advanced toward the distal end of thechamber but proximal to the second recessed area, a negative pressure isgenerated relative to an atmospheric pressure.
 69. The device of claim62, comprising a fluid receptacle disposed between the distal end of thechamber and the cannula.
 70. The device of claim 70, wherein the fluidreceptacle is configured to absorb fluid.
 71. The device of claim 70,wherein the fluid receptacle is an absorbent material.
 72. The device ofclaim 62, wherein the cannula is configured to receive a tissue samplefrom a biopsy site.
 73. The device of claim 72, wherein the cannulafurther comprises a cutting sheath configured to sever the tissue samplefrom the biopsy site.